Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA）

Launched by SHANGHAI FUDAN-ZHANGJIANG BIO-PHARMACEUTICAL CO., LTD. · May 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method for treating a type of brain cancer called malignant glioma, which is known to be aggressive. Researchers want to see if a single dose of a special medication called 5-aminolevulinic acid (5-ALA), taken by mouth, can help doctors better see and remove the tumor during surgery. The trial is open to adults aged 18 to 75 who have been diagnosed with this type of brain tumor and are planning to have surgery to remove it.

To participate, patients must give their written consent and have a certain level of health (measured by something called the Karnofsky Performance Status). However, there are some exclusions; for example, those with tumors in specific areas of the brain or certain skin conditions might not be able to join. If eligible, participants can expect to take the medication before their surgery and be closely monitored for its effectiveness and safety. This trial is currently recruiting participants, and it aims to improve how doctors perform surgery on malignant gliomas.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient's written informed consent
• • Age 18-75 years
• • Radiological suspicion of a malignant glioma
• • Indication for surgical tumour resection
• • Karnofsky Performance Status (KPS) ≥ 70
• Exclusion Criteria:
• • Tumor located in the basal ganglia, thalamus, cerebellum, or brainstem
• • Porphyria, hypersensitivity to porphyrins，history of cutaneous photosensitivity or photosensitive skin diseases；
• • known hypersensitivity to the test drug ingredients
• • Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate;